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Imprese · 27/08/20101 min di lettura

New Animal Drugs; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension

Traduzione automatica locale · Lingua originale della fonte

Riepilogo

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug application (ANADA) from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is removing those portions of the regulations that reflect approval of two other NADAs transferred from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc., for which voluntary withdrawal of approval was requested after the change of sponsorship. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these two NADAs.

Lingua originale della fonte: Federal Register — Health and Human ServicesApri il comunicato originale →

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